Mannitol to prevent an exacerbation of Complex Regional Pain Syndrome (CRPS) after hand surgery

ISRCTN	ISRCTN36315634
DOI	https://doi.org/10.1186/ISRCTN36315634
Protocol serial number	N/A
Sponsor	University Medical Centre Utrecht (UMCU) (Netherlands)
Funder	University Medical Centre Utrecht (UMCU) (Netherlands) - Department of Anesthesiology

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr M.J.M.M. Giezeman
Scientific

University Medical Center
Department of Anesthesiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands

Phone	+31 (0)30 2506163
Email	m.j.m.m.giezeman@umcutrecht.nl

Primary study design	Interventional
Study design	Randomised double blind active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does mannitol, administered intravenously for 48 hours, prevent a recurrence or an exacerbation of complex regional pain syndrome after surgery
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Complex Regional Pain Syndrome (CRPS)
Intervention	The treatment group will receive mannitol 10%, 1l daily, via a continuous IV infusion, starting at the beginning of anesthesia. In addition, a placebo tablet hydrochlorothiazide is administered twice daily, starting after surgery. The placebo group will receive 1l NaCl 0.9%, also via continuous infusion starting at the beginning of anesthesia. In addition, patients will receive a tablet of 25 mg hydrochlorothiazide twice daily. Treatment will continue for 48 hours postoperatively.
Intervention type	Other
Primary outcome measure(s)	The Impairment Level Sum Score (ISS) after 3 months, which is a composite score, accounting for pain, edema, temperature and range of motion.
Key secondary outcome measure(s)	1. Disability of Arm, Shoulder and Hand, Dutch Language Version (DASH-DLV) score 2. Individual components of ISS 3. Perioperative VAS-pain scores 4. Number of medication changes 5. Side effects
Completion date	01/01/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Age at least 18 years 2. History of CRPS, indicated by the presence of the following characteristics during the past 3 years (adapted CRPS I criteria according to Bruehl): 2.1. Continuing pain, disproportionate to any inciting event 2.2. At least 1 symptom in one of the following 4 categories: 2.2.1. Sensory: hyperalgesia 2.2.2. Vasomotor: temperature asymmetry or skin color changes or skin color asymmetry 2.2.3. Sudomotor/edema: edema or sweating changes or sweating asymmetry 2.2.4. Motor/trophic: diminished range of motion or motor dysfunction or trophic changes 3. The presence of CRPS signs is not mandatory 4. Surgery on the affected upper extremity (a.o. carpal-tunnel syndrome, joint surgery on wrist and fingers)
Key exclusion criteria	1. Allergy to mannitol 2. Allergy to hydrochlorothiazide 3. Clinically relevant renal impairment (creatinine ≥150% normal) 4. History of cardiac failure (orthopnea, edema, exertional dyspnea, admissions for cardiac failure) 5. CRPS in both upper extremities 6. Other pain syndromes affecting functional testing or pain scores 7. Infection 8. Pregnancy 9. No informed consent
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2007

University Medical Center

Utrecht
3508 GA
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan